Trial record 3 of 4 for:    Yoga | Open Studies | Exclude Unknown | NCCAM

GATE: Generalized Anxiety - A Treatment Evaluation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01912287
First received: July 29, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder.


Condition Intervention
Generalized Anxiety Disorder
Behavioral: Cognitive Behavioral Therapy
Behavioral: Stress Education
Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GATE: Generalized Anxiety - A Treatment Evaluation

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Treatment Response as Assessed by the Clinical Global Impression-Improvement (CGI-I of 1 or 2) scale [ Time Frame: Biweekly from weeks 0 through 12, and 6-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) [ Time Frame: Weeks 0, 6 , 12 and 6 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: December 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga
12 week session
Behavioral: Yoga
Other Name: Kundalini Yoga
Active Comparator: Cognitive Behavioral Therapy (CBT)
12 week session
Behavioral: Cognitive Behavioral Therapy
Other Name: CBT
Sham Comparator: Stress Education
12 week session
Behavioral: Stress Education
Other Name: SE

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder
  • Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher
  • Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
  • Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
  • For women of childbearing potential, willingness to use a reliable form of birth control

Exclusion Criteria:

  • Patients unable to understand study procedures and participate in the informed consent process.
  • Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
  • Women who are planning to become pregnant
  • Serious medical illness or instability for which hospitalization may be likely within the next year
  • Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
  • History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
  • Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
  • Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
  • Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
  • Prior experience with (more than 5 Yoga classes or CBT sessions within the last 3 years) and/or current practice of mindbody techniques (e.g., yoga, meditation, Tai-Chi, etc) or cognitive behavioral therapy (CBT)
  • Concomitant therapy for generalized anxiety disorder (GAD) (any therapy)
  • Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
  • Cognitive impairment (MOCA<21)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912287

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Allison Campbell    617-726-3508    acampbell7@partners.org   
Principal Investigator: Naomi M Simon, MD, MSc         
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Shelley Kind    617-353-9610    slkind@bu.edu   
Principal Investigator: Stefan G Hofmann, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Naomi M Simon, MD, MSc Massachusetts General Hospital
Principal Investigator: Stefan G Hofmann, PhD Boston University
  More Information

No publications provided

Responsible Party: Naomi M. Simon, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01912287     History of Changes
Other Study ID Numbers: 2013P000048, 1R01AT007258-01A1
Study First Received: July 29, 2013
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Generalized Anxiety Disorder
GAD
Yoga
CBT

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014